Homepage | ISPE | International Society for Pharmaceutical Engineering
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Indianapolis, IN 46224 United States
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Novinky
In this case study, discover how a collaboration transformed a 50-year-old warehouse into a GMP-like plasmid production facility. This was achieved by leveraging prefabricated cleanrooms. This innovative approach integrated all utility systems, allowed renovation and construction to happen in parallel, and drastically accelerated the project timeline. The result: a demonstration of how GMP-capable facilities can be mobile, rapidly deployable, and adaptable, even in minimal infrastructure environments. Read more in this case study by G-CON: https://hubs.la/Q03MyYtF0 (fb)
We are proud to celebrate Johnson & Johnson Innovative Medicine as the 2025 ISPE FOYA Category Winner for Operations – Project Execution for the expansion of their BioCork facility in Ringaskiddy, Cork, Ireland. This milestone project significantly increased biomanufacturing capacity to support the production of biologic medicines in immunology and oncology—while also generating 180 new jobs in the local community. Executed within a live manufacturing environment, the expansion achieved seamless integration without unplanned downtime, a feat made possible by precise coordination, robust risk management, and close collaboration with key partners. With 2.6 million safe man hours, over 1,100 safety audits, and a TRIR and DART of just 0.075, the project demonstrated an industry-leading commitment to safety and operational excellence. What truly sets this project apart is its innovative and sustainable execution. A fully digital, paperless approach enabled efficient commissioning and operational readiness, while drone and VR technologies accelerated collaborative decision-making. The expansion achieved LEED Silver Certification, reducing water consumption by approximately 3,000 m³ annually and eliminating over three tons of disposable materials. Delivered under budget and 11 months ahead of schedule, the project reflects Johnson & Johnson’s dedication to excellence, sustainability, and their long-standing Credo-driven focus on community and employee well-being. Congratulations to Johnson & Johnson Innovative Medicine for setting a new benchmark in biomanufacturing project delivery. Read the full blog to learn more about Johnson & Johnson's innovations: https://hubs.ly/Q03Ms3xS0 Be there when the spotlight shines. Get your ticket to the 2025 ISPE FOYA Banquet and Awards Celebration and find out who the overall winner will be: https://hubs.ly/Q03Ms3cd0 (fb)
Poslední komentáře
Absolutely thrilled to see ISPE taking the lead on elevating pharmaceutical quality! Together, we can make a difference in ensuring safety and efficacy in our industry! 🌍💊detail |
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Loving the focus on digital transformation and Pharma 4.0! Excited for the upcoming conferences and all the knowledge we can share and gain as a community! 🚀✨detail |
Poslední diskuze
1. How can ISPE members effectively leverage technology advancements like AI and ML to enhance Quality Risk Management in pharmaceutical processes?Odpovědí: 3, Naposledy před 1 den detail |
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2. What strategies can NGOs adopt to promote collaboration among stakeholders in the pharmaceutical industry for improved regulatory compliance and innovative practices?Odpovědí: 3, Naposledy před 1 den detail |
V okolí
4.5
Indianapolis
O společnosti
- U42 -
Main navigation Secondary Menu Occupational ISPE GAMP 5 A Risk Based Approach to Compliant GxP Computerized Systems Second Edition section 2. 1. 4 states Quality Risk Management QRM is a systematic process for the identification assessment control communication mitigation and review of risks. In the pharmaceutical industry ensuring the safety quality and efficacy of products is paramount.
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